Product Compliance Engineer
nLIGHT is seeking a Product Compliance Engineer to join our Quality team located in Vancouver, Washington.
Regulatory complexity is increasing and continuously evolving with many local, national and international codes, regulations, standards, and voluntary practices. Because of this, nLIGHT has recognized the requirement for a new position dedicated to executing this critical business function. The focus of this position is to identify and provide the appropriate safety and environmental certifications for the products nLIGHT designs, manufactures, and markets, and as a result, to facilitate global market expansion.
- Develop a robust and coherent product compliance program by researching, analyzing, selecting and applying compliance engineering concepts, approaches, techniques and criteria
- Research, evaluate and communicate US and International regulations and standards with the objective of making nLIGHT products compliant and satisfying customer needs
- Track and understand the regulatory environment, clearly communicate changes to Product Line Managers regarding changes that might affect existing and new business, and ensure timely and appropriate decisions are made
- Provide guidance regarding regulatory requirements to various areas including executive leadership, management, and cross-functional teams – regarding design, development, evaluation, or marketing of products to ensure regulatory requirements and standards are met.
- Develop tools and processes, and deliver training, to enable other engineers to work with a reasonable level of autonomy regarding product compliance
- Identify applicable regulatory compliance requirements for new products, create plans to obtain certifications
- Participate in design reviews and provide direction to development teams on product regulatory compliance
- Lead hands-on product compliance reviews and participate in risk analysis activities such as FMEAs for compliance related risks and mitigations
- Coordinate test execution with external labs, vendors, and internal resources.
- Ensure progress is made toward new product compliance deliverables, objectives, and timelines
- Determine budget for compliance related items
- Prepares regulatory submissions as appropriate for approval of new or modified products. Attain compliance by resolving any non-compliance issues
- Organize and maintain compliance documentation including nLIGHT and external certifications, test reports, RoHS information, etc.
- Review the content of product safety literature and product labels
- Obtaining necessary product compliance supporting documentation from suppliers
- Provide CE declarations of conformity, RoHS and REACH certifications, Conflict Minerals declarations etc. to external parties
- Manage factory inspections performed by certifying agencies
- Lead internal investigations and analysis of any suspected non-compliant product. Define or agree corrective/preventive actions as necessary. Develop feedback mechanisms into future product development activities
- Document compliance learnings and decisions
- Attain and share knowledge of the latest regulations and standards by participating in education opportunities and professional organizations, and reading professional publications
- Required: Minimum of a Bachelor’s Degree in Engineering, or Physics
- Preferred: Additional certifications related to Product Compliance
- 5 years of professional experience with at least three years of experience as a Product Compliance Engineer
- Completed at least 6 product compliance submissions, 3 of which were for new products
- Thorough understanding of how to identify US and international product and environmental regulations, standards, and practices including emerging trends
- Working knowledge of the following Industry standards:IEC 60204
- IEC 61326
- EN 55011
- ISO 9001
- ISO 12100
- ISO 31000
- Working knowledge of the following European directives:RoHS, REACH, WEEE, Low Voltage, EMC
- Previous experience working with various global and country-specific certification bodies – e.g. UL, TUV, CSA, Intertek, KETI, CQC, BRE, etc.
- Experience writing technical documents and building technical construction files
- Laser Industry experience
- Working knowledge of the IEC 60825 standard and 21CFR1040.10
- Excellent written and verbal communication skills, ranging from technical reports to executive summaries
- Ability to work at elevated levels of accuracy and detail
- Strong planning and project management skills
- Strong hands-on mechanical, electrical, and electromechanical aptitude
- Comfortable working in a fast-paced, creative environment
- The ability to work effectively with cross-functional teams and external parties is extremely important
- Intimately familiar with emerging compliance engineering practices, regulations and standards
- Self-motivated and able to manage their own work load
nLIGHT is subject to US Export Control regulations. To qualify for this position, a Foreign Person (that is, not a US Citizen or legal Permanent Resident) must be eligible for a deemed export license under the US Department of Commerce and/or the US Department of State.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or age. For more information about our commitment to equal employment opportunity, please see these government posters: “EEO is the Law” and its accompanying temporary supplement. If you are an individual with a disability and need a reasonable accommodation in the application or hiring process, please contact Human Resources at (360) 566-4460 or Hr@nlight.net.
About nLIGHT Apply for this position
nLIGHT is a rapidly growing vertically integrated supplier of high-performance lasers that enable innovation in materials processing, microelectronics and defense applications. nLIGHT develops and manufactures fiber lasers based on industry-leading semiconductor laser and optical fiber technology. nLIGHT is headquartered in Vancouver, Washington with additional sites in North America, Asia and Europe. nLIGHT lasers are not only changing the way things are made, but what can be made.